This invention relates generally to a bleed back control assembly for controlling blood loss during vascular diagnostic or interventional procedures, such as insertion and removal of catheters from the blood vessels of a patient.
Treatment of patients with diseases, such as coronary heart disease, may involve the use of catheters, balloon catheters, stents, and other vascular intervention devices which are introduced transluminally, i.e., to and through the interior of a blood vessel. Catheterization procedures often include the use of a hemostatic valve to reduce blood loss.
It is known in the art to provide a large bore rotating hemostasis valve (RHV) which attaches to the end of a guiding catheter and acts as an open/close valve. After a device is introduced into the lumen of an RHV, the RHV serves as a seal around the device to reduce blood loss. An RHV must be opened to allow introduction of an interventional device into the lumen of the RHV, and must be closed to control blood loss while allowing device adjustment, such as moving it back and forth. A doctor must adjust a screw cap of a conventional RHV in order to adjust the seal around various devices introduced axially through the lumen of the RHV. A conventional RHV may utilize a Touhy-Bourst seal design, which may be opened and closed by the user, but such a seal allows fluid to escape until properly adjusted. A significant amount of blood may be lost during these adjustments of the RHV which are required in order to move a device, such as a catheter, in and out of the RHV. When the RHV is not adjusted to seal around the device introduced in the lumen of the RHV, there is no mechanism for inhibiting substantial bleed back or blood loss.
Accordingly, a conventional RHV allows excessive blood loss when the RHV is not adjusted or whenever the RHV is in the open position. The excessive blood loss also creates a more ensanguined operating environment for the user of the RHV, increasing risks associated with unwanted exposure to blood (or other fluids) and making more difficult the manipulation or operation of devices.
The bleed back control assembly permits diagnostic or interventional vascular procedures, such as insertion of devices like catheters, guide wires, or stent delivery systems into the blood vessels of a patient, while controlling and significantly reducing the amount of blood loss, when the catheter is adjusted or moved. The bleed back control assembly includes an elastomeric bleed back control seal around the intervention device (such as, but not limited to, a catheter). In accordance with these and other aspects of the invention, the bleed back control assembly controls blood loss during insertion, movement, and removal of a vascular intervention device (such as a catheter) from the assembly.